System Instruction Manual

www.aerogen.com
Contents

Introduction 2

Indications for Use 2

System Warnings 5

Assembly & Installation 9

Installation For Use With A Ventilator 12

Nebulisation 16

Installation For Use Off-Ventilator 17

Functional Test 19

Cleaning, Disinfection and Sterilisation 20

Troubleshooting 26

Warranty 28

Life Of Product 28

Specifications 29

Performance 30

Symbols 31

Appendix 1 32

Appendix 1: EMC Tables 34

Aerogen® Pro System Instruction Manual 1

 Introduction
The Aerogen® Pro System is a portable medical device for multiple patient
use that is intended to aerosolise physician-prescribed medications for
inhalation that are approved for use with a general purpose nebuliser. This
device can be used by patients on and off mechanical ventilation or other
positive pressure breathing assistance.

Aerogen® Pro is suitable for use by neonate, paediatric to adult patients

as described in this manual. It incorporates the Aerogen Vibronic® aerosol
generator.

Aerogen® Pro is intended for hospital use only. It is designed to operate in-
line with standard ventilator circuits and mechanical ventilators. It operates
without changing patient ventilator parameters and can be refilled without
interrupting ventilation.

The controller operates from the AC/DC adapter and can be operated on
its internal rechargeable battery for up to 45 minutes when fully charged.
The product operates without compressed gas, making it suitable for
portable applications.

Indications for Use

The Aerogen Pro System is a portable medical device for multiple patient
use that is intended to aerosolise physician-prescribed solutions for
inhalation to patients on and off ventilation or other positive pressure
breathing assistance. The Aerogen Pro System is suitable for use in adult,
paediatric and neonate patients.

2 Aerogen®
Aerogen Pro System

The Aerogen Pro System includes the following components:

1 2 3 4

5 6

Figure 1.  Aerogen Pro System

1. Nebuliser with Filler Cap

2. T-Piece (Adult) with Plug

3. Aerogen Pro Controller

4. Controller Cable

5. AC/DC Adapter

6. Universal Mounting Bracket & Equipment Mount Adapter

Note:  Device names previously referencing ‘Aeroneb’ are now referencing

‘Aerogen’. Visit www.aerogen.com for full parts list.

Aerogen® Pro System Instruction Manual 3

1. The nebuliser holds up to 10 mL of liquid medication. The nebuliser
is translucent to allow visual monitoring of medication levels and
aerosolisation. When the nebuliser is connected into the breathing
circuit, the filler cap can be opened or removed from the nebuliser
without causing loss of circuit pressure.

Within the nebuliser is the Aerogen Vibronic® aerosol generator, which
consists of a domed aperture plate with precision-formed holes that
control the size of the aerosol droplets and a vibrational element that
creates micro-pumping action to aerosolise medication. Gravity brings
the medication in contact with the aerosol generator; the liquid is then
drawn through the aperture plate and converted into an aerosol.

2. The T-piece securely connects the nebuliser into the breathing circuit
and can be easily removed for cleaning. The T-piece connections are
standard male and female 22 mm ISO conical ports and connect to
standard patient breathing circuits.

3, 4, 5.
The controller can operate from the AC/DC Adapter or the internal
rechargeable battery. The controller includes an On/Off power button
and sockets for the controller cable and the AC/DC Adapter. The
controller also includes indicators for nebulisation cycle selection (15
or 30 minutes), battery charge status and fault conditions.

6. A Universal Mounting Bracket clamps the controller to standard IV

poles and medical rail systems.

7. An Equipment Mount Adapter mounts the controller on Standard

Equipment Mounts.

Note:  Paediatric T-piece, Neonate Adapters, Mask Adapter Kits, Elbow

Connectors and Mouthpiece are sold separately.

4 Aerogen®
System Warnings
Read and study all instructions before using the Aerogen Pro System
and accessories. Only trained medical personnel should operate the
device.

During use observe for correct functioning of the nebuliser by regularly

verifying aerosol is visible and no flashing indicator lights.

Do not use a filter or heat-moisture exchanger (HME) between the nebuliser

and patient airway.

Do not attach a continuous supply of medication to the nebuliser; the

device operates in 15 or 30 minute cycles.

Clean, sterilise, assemble and perform a functional test (page 19) according
to the instructions in this manual before first use and between patients.

Do not place the controller in an incubator during use.

To avoid exhaled medication affecting the ventilator, follow ventilator

manufacturer’s recommendations for use of a bacterial filter in the
expiratory limb of a breathing circuit.

To ensure optimum drug administration, consult the drug manufacturer’s

instructions regarding suitability for nebulisation.

Do not use in the presence of flammable substances or a flammable

anaesthetic mixture combined with air or with oxygen or nitrous oxide.

To avoid the risk of fire do not use to aerosolise alcohol-based medications,

which can ignite in oxygen-enriched air under high pressure.

Do not modify this equipment without the authorisation of the manufacturer.

Disconnect the nebuliser from controller before cleaning.

Aerogen® Pro System Instruction Manual 5

Inspect all parts before use, and do not use if any parts are missing,
cracked or damaged. In case of missing parts, malfunction or damage,
contact your sales representative.

Do not immerse or autoclave the controller or AC/DC adapter.

Disassemble all parts before autoclaving.

Use only with components specified by Aerogen.

Do not use or store outside of specified environmental conditions.

To avoid mechanical or electrical damage, do not drop the nebuliser or

the controller.

Do not use in the presence of devices generating high electromagnetic

fields such as magnetic resonance imaging (MRI) equipment.

The Aerogen Pro controller contains a nickel metal hydride (NiMH)

rechargeable battery, which should be disposed of in accordance with
local governing restrictions at the end of its useful life.

To avoid damage to the nebuliser:

•• Prior to use, autoclave according to specified directions and

temperature given in the Cleaning, Disinfection and Sterilisation
section of this Instruction Manual only. Any deviation from directions
given in this Instruction Manual may cause damage to the nebuliser
and render it inoperable.

•• Do not apply undue pressure to the domed aperture plate in the centre
of the nebuliser.

•• Do not push out the Aerogen Vibronic® aerosol generator.

•• Do not use a syringe with a needle to add medication.

•• Do not use abrasive or sharp tools to clean the nebuliser.

6 Aerogen®
Aerogen Pro Controller

On/Off Power
• 15 Min. - Press & Release
• 30 Min. - Press & hold for 3 Sec.

Error Indicator

30 Minute Mode
Indicator light

15 Minute Mode
Indicator light
Battery Status
Indicator

9V DC Input

Controller
Cable Input

Figure 2.  Aerogen Pro Controls & Indicators

Aerogen® Pro System Instruction Manual 7

 Table 1.  Aerogen Pro Controls & Indicators

Control / Indicator Function

• Green (steadily lit) = 15 Minute

nebulisation cycle on
15 Min. Indicator • Green (flashing) = Low battery power
• Nebuliser automatically powers off after
15 minutes have elapsed

• Green (steadily lit) = 30 Minute

nebulisation cycle on
30 Min. Indicator • Green (flashing) = Low battery power
• Nebuliser automatically powers off after
30 minutes have elapsed

Error Indicator • Amber = Faulty electrical connection

• To operate in 15 Minute Mode, press and

immediately release the On/Off button
• To operate in 30 Minute Mode, press
On/Off Power Button and hold the On/Off button for at least 3
seconds from off
• Pressing during nebulisation turns off
power to the nebuliser

• Green = Battery fully charged

Battery Status Indicator • Amber = Battery charging
• No light = Battery in operation

Recharging the Battery

To recharge the battery, connect the AC/DC Adapter to the controller and
connect to AC power source. The battery status indicator is amber while
charging and green when fully charged.

If the controller is placed in long-term storage, it is recommended that the

battery be recharged every 3 months.

Allow a minimum of four hours for the internal battery to fully recharge.

8 Aerogen®
Assembly & Installation
Aerogen Pro System Set-Up

Clean and sterilise the nebuliser and T-piece(s) as described in the

Cleaning, Disinfection and Sterilisation section of this manual.

Note:  The nebuliser and T-piece, as packaged, are not sterile.

1 Perform a functional test of Aerogen Pro before use and between
patients as described in the Funtional Test section of this manual
(see page 19).

2 Insert the filler cap into the opening on the nebuliser.



3 Connect the nebuliser to the T-piece by pushing the nebuliser firmly
onto the T-piece (Figure 3).

Figure 3.  Connecting nebuliser to T-piece

Aerogen® Pro System Instruction Manual 9

 4 Connect the Aerogen Pro controller and the nebuliser together using
the controller cable (Figure 4).

Figure 4.  Connecting controller and nebuliser

5 To operate on AC power (the primary mode of operation), connect

the Aerogen Pro AC/DC adapter to the Aerogen Pro controller
and plug the adapter into an AC power source (Figure 5).

Figure 5.  Connecting the AC/DC Adapter

10 Aerogen®
 6 The Aerogen Pro can be battery-operated for portable applications.
The rechargeable battery can power the System for up to 45 minutes
when fully charged. In the case of AC power failure the controller will
automatically switch to battery operation.

Note:  Allow a minimum of four hours for the internal battery to fully
recharge.

Note:  To ensure uninterrupted operation of the Aerogen Pro, secure both

the AC/DC adapter cable and the controller cable so they cannot become
disconnected during treatment. If clips are available on patient circuits, run
the cables through the eyes of the clips. If clips are not available, ensure
that all cables are routed safely.

Aerogen® Pro System Instruction Manual 11

 Installation for use with a Ventilator
Connection to a Breathing Circuit
1. For adult breathing circuits, connect the nebuliser with adult T-piece
into the inspiratory limb of the breathing circuit before the patient Y
(Figure 6).

Figure 6.  Connecting the Aerogen Pro to an adult breathing circuit

Note:  Figure 6 shows adult configuration only

For paediatric breathing circuits, connect the nebuliser with the

paediatric T-piece into the inspiratory limb of the breathing circuit
before the patient Y (Figure 7).

Figure 7.  Connecting to a paediatric breathing circuit

12 Aerogen®
Figure 8.  Connecting to a neonatal breathing circuit using neonate T-piece

For neonatal breathing circuits, connect the nebuliser with the

paediatric T-piece and the neonate adapters approximately 30 cm
(12 in.) back from the patient Y (Figure 7). Alternatively connect the
nebuliser with the Neonate T-piece 30 cm (12 in.) back from the patient
Y (Figure 8).

2. Always perform a leak test of the breathing circuit after inserting or

removing the nebuliser. Follow ventilator manufacturer instructions for
performing a leak test.

3. Use the universal mounting bracket to attach the controller to an IV

pole or bed rail in either a vertical or horizontal orientation (Figure 9). Do
not over-tighten knob.

Where a standard equipment mount is available, use the equipment

mount adapter to support the controller (Figure 9).

Aerogen® Pro System Instruction Manual 13

 Standard
Equipment Mount

Controller and Vertical Controller and Horizontal Equipment

Universal Mounting Bracket Universal Mounting Bracket Mount Adapter

Figure 9.  Aerogen Pro controller and universal mounting bracket

configurations

Warnings
• Always maintain the nebuliser in a vertical orientation (with the filler cap
uppermost) while in the patient circuit (Figures 6, 7, & 8). This orientation
prevents condensate from blocking the nebuliser and ensures proper
nebulisation. Always visually inspect the nebuliser prior to placing
in the ventilator circuit to assure that no secretions are blocking the
Aerogen Vibronic® aerosol generator.
• When removing the nebuliser from the patient circuit always replace
the T-piece plug to maintain circuit pressure.
• Always connect a bacteria filter to the expiratory inlet of the ventilator.
Otherwise the function of the expiratory channel may be degraded.
• Do not use a filter or heat-moisture exchanger (HME) between the
nebuliser and patient airway.

14 Aerogen®
Adding Medication
•• Open the filler cap tab on the nebuliser.

•• Use a pre-filled ampoule or syringe to add medication into the filler port
of the nebuliser (Figure 10).

•• Close the filler cap tab.

Warning: To avoid damage to the nebuliser, do not use a syringe with a

needle.

The maximum capacity of the nebuliser is 10 mL. Do not fill the nebuliser
beyond the maximum fill indication point (Figure 10). The underside of the
filler cap represents maximum fill indication point.

Max. fill
indication
point

Figure 10.  Filling the nebuliser with a pre-filled ampoule

Note:  Medication can be added in this manner during nebulisation. This

does not interrupt nebulisation or ventilation.

Aerogen® Pro System Instruction Manual 15

 Nebulisation
For doses less than or equal to 3 mL.

1. To start a 15 Minute nebulisation cycle, add the medication and press

and release the blue On/Off power button (Figure 2). The green 15 Min.
indicator lights to indicate that the 15 Minute nebulisation cycle is in
progress.

For doses greater than 3 mL.

2. To start a 30 Minute nebulisation cycle, add the medication and press

and hold the blue On/Off power button for at least three seconds. The
green 30 Min. indicator lights to indicate that the 30 Minute nebulisation
cycle is in progress.

3. To stop the nebuliser at any time, press the On/Off power button. The
indicator turns off to indicate that nebulisation has stopped.

Note:  When delivering a dose greater than 3 mL, select the 30 Minute
cycle.

16 Aerogen®
Installation for use Off-Ventilator
Use with a Face Mask

Mask kits, which include a vented elbow and mask elbow, are available
separately (visit www.aerogen.com for full parts list). Contact your sales
representative for ordering information.

1. When using a mask, connect the vented elbow, mask elbow and mask
to the nebuliser by firmly pushing the parts together.

2. Rotate the vented elbow to suit the position of the patient (Figure 11).

Vented
Vented FaceFace
MaskMask
Elbow
Elbow Elbow
Elbow

Patient
Patient
Upright
Upright Patient
Patient
Reclined
Reclined

Figure 11.  Connecting to a mask

Warning: To ensure correct nebulisation, maintain the nebuliser in a

vertical orientation (Figure 11).

Use with a Mouthpiece

The Aerogen Pro works with any standard ISO 22 mm nebuliser mouthpiece
inserted into the adult T-piece.

Figure 12.  Connecting to a mouthpiece

Aerogen® Pro System Instruction Manual 17

 When using a mouthpiece, connect the nebuliser to the T-piece as shown
in Figure 3 and then connect the T-piece to the mouthpiece by pushing the
parts firmly together (Figure 12).

Warning: To ensure correct nebulisation, maintain the nebuliser in a

vertical orientation (Figure 12).

18 Aerogen®
Functional Test
Perform a functional test of the Aerogen Pro System prior to first use, after
each sterilisation before each patient use or at any time to verify proper
operation. Follow these steps:

1. Visually inspect each part of the system for cracks or damage and
replace if any defects are visible.

2. Pour 1-5 mL of normal saline (0.9%) into the nebuliser.

3. Connect the nebuliser to the controller using the controller cable.

Connect the AC/DC Adapter to the controller and plug the AC/DC
Adapter into an AC power source.

4. Press and release the blue On/Off power button and verify that the
green 15 Min. indicator light illuminates and that aerosol is visible.

5. Disconnect the nebuliser from the controller. Verify that the amber
Error Indicator lights. Reconnect the nebuliser to the controller.

6. Press the On/Off power button again to turn the system off. Press and
hold the button for at least three seconds. Verify that the green 30 Min.
indicator light illuminates and that aerosol is visible.

7. Disconnect the controller from the AC/DC Adapter and verify that
nebulisation continues and that the battery status indicator turns off.

8. Turn the system off and verify that the 15 Min. and 30 Min. indicators
are off.

9. Discard any remaining liquid before patient use.

Aerogen® Pro System Instruction Manual 19

Cleaning, Disinfection and Sterilisation
This section describes how to clean, disinfect, sterilise and inspect
Aerogen Pro System components. It is important that Aerogen Pro device
components are cleaned and sterilised prior to first patient use. The
components are:

•• Aerogen Pro (including filler cap)

•• T-piece (including T-piece plug) for adult and paediatric

•• Neonate Adapters

•• Aerogen Pro Controller*

•• Controller Cable* and AC/DC Adapter*

•• Mounting Bracket*

* Components not to be autoclaved.

Warning: Always clean, sterilise and disinfect in accordance with current

hospital protocols.

To avoid damage to the nebuliser:

•• Autoclave according to specified directions and temperature given in

the Cleaning, Disinfection and Sterilisation section of this Instruction
Manual only. Any deviation from directions given in this Instruction
Manual may cause damage to the nebuliser and render it inoperable.

•• Do not apply undue pressure to the domed aperture plate in the centre
of the nebuliser.

•• Do not push out the Aerogen Vibronic® aerosol generator.

20 Aerogen®
Manual Cleaning
Cleaning nebuliser, T-pieces and Neonate Adapters

1. Ensure there is no medication remaining in the device.

2. Remove nebuliser from T-piece. Remove filler cap from nebuliser.

3. Clean all parts with warm water and mild liquid detergent.

4. Rinse parts with sterile water.

5. Shake excess water from parts and allow parts to fully air dry.

Warning: Do not use abrasive or sharp tools to clean the nebuliser.

Disinfection
Aerogen Pro nebuliser, T-pieces and Neonate Adapters with
disinfection agents.

1. Follow steps 1 through 3 in Manual Cleaning section.

2. Completely immerse parts in appropriate disinfecting agent in

accordance with current hospital protocols and disinfectant agent
manufacturer guidelines.

Note:  Aerogen approves the following disinfection solutions for use with
its Aerogen Pro nebulisation system regarding material compatibility. With
respect to microbiological effectiveness, please ask the manufacturer.
Refer to the product labelling for specific instructions regarding activation,
safe use and disposal of these solutions.
•• Isopropyl (70%)
•• CIDEX®
•• NU-CIDEX®
•• CIDEX® OPA
•• Hexanios G+R

Warning: The use of any other means of cleaning, disinfection or

sterilisation has not been qualified and is likely to reduce the life of your
nebuliser and will invalidate your warranty.

Aerogen® Pro System Instruction Manual 21

 Automated Washing Cycle
The Aerogen Pro nebuliser system has been qualified for the following
automated washing cycles.

Automated Cycle One

Detergent: Liquid alkaline cleaner (diluted as per manufacturers
instruction).
Water Quality: Mains water.

Method:

1. Load the components in the automated washer.

2. Pre-rinse the components for 3 minutes.

3. Clean the components with liquid alkaline cleaner at 55 °C (131 °F) for
10 minutes.

4. Rinse for 1 minute.

5. Rinse using thermal disinfection cycle at 93 °C (199.4 °F) for 10 minutes.

Automated Cycle Two

Detergent: The following cycle was validated without the use of a
detergent.
Water Quality: Mains water.

Method:

1. Load the components in the automated washer.

2. Wash components for 10 minutes at 91 °C (195.8 °F).

3. Drain the machine for 40 seconds.

4. Rinse at 90 °C (194 °F) for 1 minute.

5. Drain the machine for 40 seconds.

6. Rinse at 90 °C (194 °F) for 1 minute.

7. Drain the machine for 40 seconds.

8. Dry at 90 °C (194 °F) for 15 minutes.

22 Aerogen®
Sterilisation of the Aerogen Pro Nebuliser
Sterilisation of Aerogen Pro Nebuliser, T-Pieces & Neonate Adapters

1. Disconnect the nebuliser from the controller, and then remove the
nebuliser and adapters from the ventilator circuit, mask or mouthpiece.

2. Disassemble the nebuliser and adapters into individual components.

3. Remove the filler cap from the nebuliser.

4. Clean all parts with warm water and mild liquid detergent in accordance
with current hospital protocols. Rinse thoroughly and air dry.

5. Check for cracks or damage and replace if any defects are visible.

6. Place the disassembled components into appropriate sterilisation

wrapping.

Warning: Do not reassemble parts prior to autoclaving.

Sterilise Components
Steam sterilisation can be performed using the following three methods:

1. Autoclave wrapped parts using steam sterilisation pre-vacuum cycle,

a minimum of 134 °C (270 °F - 275 °F) for 3.5 minutes with drying cycle
(134 °C wrapped cycle).

2. Autoclave wrapped parts using steam sterilisation pre-vacuum cycle,

a minimum of 121 °C (250 °F) for 20 minutes with drying cycle (121 °C
wrapped cycle).

3. Autoclave wrapped parts using steam sterilisation pre-vacuum cycle,

a minimum of 134 °C (270 °F - 275 °F) for 20 minutes with drying cycle
(sometimes referred to as a “Prion cycle”).

Note:  Sterilisation using the long autoclave cycle (No. 3 above) may cause
some areas of the nebuliser to become discolored. This is not indicative of
the performance of the nebuliser.

 o sterilise with hydrogen peroxide gas plasma, place wrapped parts in a

T
STERRAD® System and use the long cycle.

Aerogen® Pro System Instruction Manual 23

Warning: Users should refer to the product labelling for the STERRAD®
100S Sterilisation System for specific instructions regarding its correct
operation.

Prior to next use:

1. Check for cracks or damage and replace if any defects are visible.

2. Perform a functional test as described in this manual.

24 Aerogen®
Cleaning the Aerogen Pro Controller
Cleaning of controller, controller cable & AC/DC adapter

1. Wipe clean with an alcohol based disinfectant wipe or a quaternary

ammonium compound based disinfectant wipe.

2. Check for exposed wiring, damaged connectors, or other defects and

replace if any are visible.

3. Visually inspect for damage and replace the controller if any damage
is observed.

Warnings
• Do not autoclave.

• Do not use abrasive or sharp tools.

• Do not spray liquid directly onto the controller.

• Do not immerse controller in liquid.

Note:  The Aerogen Pro nebuliser contains active electronic components.

Aerogen has validated the methods of cleaning, disinfection and
sterilisation above. The use of any other means of cleaning, disinfection
or sterilisation has not been validated and is likely to reduce the life of your
nebuliser and will invalidate your warranty.

Cleaning of mounting brackets

Wipe clean with a damp cloth and mild liquid detergent. Do not use
abrasive or sharp tools.

Aerogen® Pro System Instruction Manual 25

Troubleshooting
If these suggestions do not correct the problem, discontinue use of any
device and contact your local Aerogen sales representative.

Table 2.  Aerogen Pro Troubleshooting

If this happens: It could mean: Try this:

The 15 Min. or 30 Min.
Recharge battery
indicator flashes during Battery power is low.
(see Recharging the Battery).
nebulisation.
Battery will not
recharge.
Constant green light
showing on the battery
status indicator and
It may be time to replace Contact your local Aerogen
flashing green light on
the battery. sales representative.
either the 15 Min. or
30 Min. indicator light,
when the controller is
connected to the AC/DC
Adapter.

Battery will not retain Rechargeable battery may Contact your local Aerogen
initial charge. need to be replaced. sales representative.

Refill medication through filler

No medication in nebuliser.
The 15 Min. or 30 Min. Nebuliser has not been
light illuminates, but cleaned properly.
aerosol is not visible.
It may be time to replace
the nebuliser.
15 Min. or 30 Min. There is no power to the
indicator does not light system.
when On/Off power
button is pressed. Rechargeable battery is
depleted.
The controller cable is
The fault indicator light incorrectly connected to
illuminates. the nebuliser, or electronics
are malfunctioning.
cap in the nebuliser (see page
15).
Clean nebuliser (see page
20)
See Warranty and Life of
Product. Refer to Aerogen
Pro parts list by visiting
www.aerogen.com.
Verify that AC/DC adapter
is securely attached to
controller.
Recharge battery (see
Recharging the Battery).
Verify that controller cable
is correctly connected to
both the nebuliser and the
controller.

26 Aerogen®
 Table 2.  Aerogen Pro Troubleshooting (Continued)

If this happens: It could mean: Try this:

Rechargeable battery is Recharge battery (see
depleted. Recharging the Battery).
Longer than expected
treatment time. e.g. 3 Nebuliser has not been Clean nebuliser (see page
mL of Normal Saline properly cleaned. 20).
(0.9%) should take no
See Warranty and Life of
longer than 15 minutes
It may be time to replace Product. Refer to Aerogen
to nebulise.
the nebuliser. Pro parts list by visiting
www.aerogen.com.
Ensure that nebuliser is
Nebuliser was not turned
connected to power and
on or connected to power.
turned on.
Rechargeable battery is Recharge battery (see
depleted. Recharging the Battery).
Nebuliser has not been Clean nebuliser (see page
Medication is left in properly cleaned. 20).
the nebuliser after
A 15 Minute cycle was Run an additional 15 Minute
nebulisation cycle.
selected and a volume cycle. When delivering a dose
greater than 3 mL was greater than 3 mL select the 30
added to the nebuliser. Minute cycle.
See Warranty and Life of
It may be time to replace Product. Refer to Aerogen
the nebuliser. Pro parts list by visiting
www.aerogen.com.

Note:  The rechargeable battery in the Aerogen Pro controller should only
be replaced by Aerogen authorised personnel: contact your Aerogen sales
representative.

Aerogen® Pro System Instruction Manual 27

 Warranty
The Aerogen Pro nebuliser is warranted for one year from date of purchase
against defects in manufacturing. The Aerogen Pro controller and AC/DC
Adapter are warranted for a period of two years from the date of purchase
against defects in manufacturing. All warranties are based on typical
usage.

Life of Product
As with all active electronic components, the Aerogen Pro nebuliser has a
defined life. In the case of Aerogen Pro controller, the life of the controller
unit has been validated for use for 1460 doses. This is based on a typical
product usage profile over a two year period, including four treatments per
day, 50% of the time.

The life of the Aerogen Pro nebuliser and components have been validated
for use for 730 doses and 26 autoclave treatments based on a typical one
year usage profile of four treatments per day and one sterilisation per
week, where the device is assumed to be in service for 50% of the time.
The user should note that any use in excess of this may result in reduced
life of the product.

28 Aerogen®
Specifications
Table 3.  Physical Specifications of the Aerogen Pro System

Nebuliser Dimensions
Aerogen Pro Controller
Dimensions
Controller Cable Length
AC/DC Adapter Cable Length
Nebuliser Weight
Aerogen Pro Controller Weight
Nebuliser Capacity
45 mm H x 50 mm W x 50 mm D
1.8” H x 2.0” W x 2.0” D
33mm H x 75mm W x 131mm D
1.3” H x 2.9” W x 5.2”D
1.8 m (5.9 ft.)
2.1 m (6.7 ft.)
25 g (0.9 oz) nebuliser and filler cap
230 g (8.1 oz.), including battery and cable
Maximum 10 mL

Table 4.  Environmental Specifications of the Aerogen Pro System

Maintains specified performance at circuit pressures up to 90cm

H2O and temperatures from 5 ºC (41ºF) up to 45 ºC (113ºF).

Operating Atmospheric Pressure 450 to 1100 hPa

Humidity 15% to 95% relative humidity
Noise Level < 35 dB measured at 0.3 m distance
Transient Temperature
-20 to +60°C (-4 to +140°F)
Range
Storage & Transport
Atmospheric Pressure 450 to 1100 hPa
Humidity 15 to 95% relative humidity

Table 5.  Power Specifications of the Aerogen Pro System

Can operate from AC/DC Adapter (input 100 to 240 VAC 50 – 60

Hz, output 9 V) or internal rechargeable battery (4.8 V nominal
output).
Power Source
Note:  The Aerogen Pro controller is approved for use with
Aerogen AC/DC adapter AG-AP1040-XX* (Manufacturer
Reference: FRIWO FW7660/09)
Power Consumption < 6.5 Watts (charging), 2.0 Watts (nebulising).
Controller circuitry provides 4 kilovolt (kV) patient isolation and
Patient Isolation
complies with IEC/EN 60601-1.

* Consult your local representative for the order number extension specific
to your country and for pricing information.

Aerogen® Pro System Instruction Manual 29

Performance
Table 6.  Performance Specifications of the Aerogen Pro

Flow Rate > 0.2 mL/min (Average ~ 0.4 mL/min)

As measured with the Andersen Cascade Impactor:
Specification Range: 1-5 μm
Average Tested: 3.1 μm

As measured with the Marple 298 Cascade Impactor:

Specification Range: 1.5-6.2 μm
Particle Size
Average Tested: 3.9 μm

As per EN 13544-1, with a starting dose of 2 mL:

Aerosol Output rate: 0.24 mL/min
Aerosol Output: 1.08 mL emitted of 2.0 mL dose
Residual Volume: <0.1 mL for 3 mL dose
Performance may vary depending upon the type of drug and nebuliser used. For
additional information contact Aerogen or drug supplier.
The temperature of the medication will not rise more than 10°C (18°F) above ambient
during normal use.

Representative particle size distribution for Albuterol as per EN 13544-1

is shown below.
Cumulative Undersize %

100%

80%

60%

40%

20%

0%
0.1 1 10
Particle Size (µm)

30 Aerogen®
Symbols

Table 7.  Aerogen Pro System Symbols

Symbol Meaning Symbol Meaning

Serial number
designation, where
Transient storage
YY is the year of
YYXXXXX temperature limitations
manufacture and
-20 ºC to +60 ºC
XXXXX is the serial
number
Caution
Quantity
Attention: Consult (Number of units
accompanying contained in package)
documents
Certified by TUV with
Degree of protection
respect to electric
against
shock, fire and
IPX1 dripping water
mechanical hazards

Class II equipment per Controller Input - DC

IEC/EN 60601-1 voltage

Type BF equipment per Controller Output – AC

IEC/EN 60601-1 voltage

On/Off power button

Output
(standby)

Timer selection (to

select the 15 Minute or
Battery status indicator
30 Minute nebulisation
cycles)
Federal (US) Law
restricts this device to Refer to instruction
Rx Only
sale by or on the order manual/booklet
of a physician.

Aerogen® Pro System Instruction Manual 31

 Appendix 1
Electromagnetic Susceptibility

This device meets the requirements of the Electromagnetic Compatibility

(EMC), pursuant to the Collateral Standard, IEC/EN 60601-1-2, which
addresses EMC in North America, Europe and other global communities.
This includes immunity to radio frequency electric fields and electrostatic
discharge, in addition to the other applicable requirements of the
standard. Compliance with EMC standards does not mean a device has
total immunity; certain devices (cellular phones, pagers, etc.) can interrupt
operation if they are used near medical equipment. Follow institutional
protocol regarding the use and location of devices that could interfere with
medical equipment operation.

Note:  This device is classified as Class II Type BF medical electrical

equipment and the device complies with specified safety levels for
electrical isolation and leakage current. The Aerogen Pro AC/DC
Adapter (AG-AP1040-XX*) has no connection to earth ground because
the necessary level of protection is achieved through the use of double
insulation.

Warnings
• Only use the Aerogen Pro nebuliser with components specified in the
Instruction Manual. Use of the Aerogen Pro nebuliser with components
other than those specified in the Instruction Manual may result in
increased emissions or decreased immunity of the Aerogen Pro
nebuliser system.
• Do not use the Aerogen Pro adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the device should
be observed to verify normal operation in this configuration.
• The Aerogen Pro needs special precautions regarding electromagnetic
compatibility (“EMC”) and must be installed and put into service
according to the EMC information provided in the Instruction Manual.

32 Aerogen®
• Portable and mobile radio frequency (“RF”) communication devices
can disrupt medical electrical equipment.

* Consult your local representative for the order number extension specific
to your country and for pricing information.

Aerogen® Pro System Instruction Manual 33

Appendix 1: EMC Tables
The following tables are provided in accordance with IEC/ EN 60601-1-2

Guidance and manufacturer’s declaration – electromagnetic emissions

The Aerogen Pro nebuliser system is intended for use in the electromagnetic
environment specified below. The customer or the user of the Aerogen Pro nebuliser
system should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment -
Guidance
RF Emissions Group 1 The Aerogen Pro nebuliser system
CISPR 11 uses RF energy only for its internal
function. Therefore, its RF emissions
are very low and are not likely to cause
any interference in nearby electronic
equipment.
RF Emissions Class B The Aerogen Pro nebuliser system is
CISPR 11 suitable for use in all establishments,
including domestic establishments and
Harmonic emissions Not
those directly connected to the public
IEC/EN 61000-3-2 Applicable
low voltage power supply network that
Voltage fluctuations / flicker Not supplies buildings used for domestic
emissions Applicable purposes.
IEC/EN 61000-3-3

34 Aerogen®
Recommended separation distances between portable and mobile RF
communication equipment and the Aerogen Pro nebuliser system that is not life
supporting
This Aerogen Pro nebuliser system is intended for use in the electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user
of the Aerogen Pro nebuliser system can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Aerogen Pro nebuliser system as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter m
output power of
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter W
d = [1.17] √P d = [1.17] √P d = [2.33] √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.75
1 1.17 1.17 2.33
10 3.70 3.70 7.36
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (w) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

Aerogen® Pro System Instruction Manual 35

 Guidance and manufacturer’s declaration – electromagnetic immunity for the
Aerogen Pro nebuliser system that is not life supporting
This Aerogen Pro nebuliser system is intended for use in the electromagnetic
environment specified below. The customer or the user of the Aerogen Pro nebuliser
system should assure that it is used in such an environment.
IEC/EN 60601 Compliance Electromagnetic
Immunity Test
Test Level Level Environment - Guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood,
discharge (ESD) concrete or ceramic tile.
±8 kV air ±8 kV air If floors are covered with
IEC/EN synthetic material, the
61000-4-2 relative humidity should be at
least 30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality
Transient/burst supply lines supply lines should be that of a typical
commercial or hospital
IEC/EN ±1 kV for input/ ±1 kV for input/ environment.
61000-4-4 output lines output lines
Surge ±1 kV differential ±1 kV differential Mains power quality
mode mode should be that of a typical
IEC/EN commercial or hospital
61000-4-5 ±2 kV common ±2 kV common environment.
mode mode
Voltage <5 % Ut <5 % Ut Mains power quality
dips, short (>95 % dip in Ut) (>95 % dip in Ut) should be that of a typical
interruptions for 0.5 cycle for 0.5 cycle commercial or hospital
and voltage environment. If the user of
variations on 40 % Ut 40 % Ut the Aerogen Pro nebuliser
power supply (60 % dip in Ut) (60 % dip in Ut) system requires continued
input lines for 5 cycles for 5 cycles operation during power
mains interruption, it is
IEC/EN 70 % Ut 70 % Ut recommended that the
61000-4-11 (30 % dip in Ut) (30 % dip in Ut) Aerogen Pro nebuliser
for 25 cycles for 25 cycles system be powered from an
uninterruptible power supply
<5 % Ut <5 % Ut or battery.
(>95 % dip in Ut) (>95 % dip in Ut)
for 5 sec for 5 sec
Power 3 A/m 3 A/m Power frequency magnetic
frequency fields should be at levels
(50/60 Hz) characteristic of a typical
Magnetic field location in a typical
commercial or hospital
IEC/EN environment.
61000-4-8
Note: Ut is the A.C. mains voltage prior to application of the test level.

36 Aerogen®
Guidance and manufacturer’s declaration - electromagnetic immunity
This Aerogen Pro nebuliser system is intended for use in the electromagnetic
environment specified below. The customer or the user of the Aerogen Pro nebuliser
system should assure that it is used in such an environment.
IEC/EN 60601 Compliance Electromagnetic
Immunity Test
Test Level Level Environment - Guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Aerogen Pro nebuliser
system, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.

Recommended Separation Distance

Conducted RF 3 Vrms [3]V d = [1.17] √P
IEC/EN 61000-4-6 150 kHz to 80 MHz d = [1.17] √P... 80MHz to 800MHz
d = [2.33] √P... 800MHz to 2.5GHz
where P is the maximum output
Radiated RF 3 V/m [3]V power rating of the transmitter
IEC/EN 61000-4-3 80 MHz to 2.5 GHz in Watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
metres (m).

Field strengths from fixed RF

transmitters, as determined by an
electromagnetic site survey,ª should be
less than the compliance level in each
frequency range.b

Interference may occur in the vicinity

of equipment marked with the
following symbol:

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

a) F
 ield strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Aerogen Pro nebuliser system is used exceeds the applicable
RF compliance level above, the Aerogen Pro nebuliser system should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orientating or relocating the Aerogen Pro nebuliser system.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m

Aerogen® Pro System Instruction Manual 37

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38 Aerogen®
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